RU2673111C2 - Template for cutting out heart valve leaflets - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: claimed group of inventions refers to a medical technique, namely, a template for cutting out the heart valve leaflets and a method for manufacturing a material of the leaflets used in aortic valvuloplasty or aortic valve reconstruction. Template includes a part forming a base of the leaflets, having a shape corresponding to the base of the leaflets so as to mark the line along part (11) forming the base of the leaflets. Template contains part (15) forming the wings of the leaflets, which corresponds to a part of the wings provided outside part (11) forming the base of the leaflets so as to mark a part of the wing. Method for manufacturing the material of the leaflets used in aortic valvuloplasty or aortic valve reconstruction involves marking the base of the leaflets on the membrane by marking the line along part (11) forming the base of the leaflets in template (13). In this case, part (11) forming the base of the leaflets has a shape corresponding to the base of the leaflets. Then, one or more marks corresponding to the wing part on the membrane are marked, using part (15) forming the wings of the leaflets in template (13). Herewith a part of the wing is provided with the possibility of performing it outside part (11) forming the base of the leaflets. Then, the membrane is cut out taking into account the position of one or several marks.EFFECT: technical result is a uniform distribution of the stress acting on the valve leaflets and the creation of stronger valve leaflets.11 cl, 7 dwg

Description

FIELD OF THE INVENTION

[0001]

The present invention relates to a template for cutting the valves of the heart valve during, for example, surgery using the technique of aortic valvuloplasty, and (or) during reconstruction of the aortic valve, and used for cutting from the material of the valves of the heart valve in the form of an artificial membrane or biomembrane.

BACKGROUND OF THE INVENTION

[0002]

Japanese Patent Publication No. 5106019 (hereinafter referred to as Patent Document 1, described below) discloses a pattern for cutting out heart valve flaps. In this document, the template includes or contains: a generally semicircular forming the base of the casement part, having as its diameter the sum of the nominal diameter (the diameter of the cylinder forming the curved surface of the sizer block, the size of which is consistent with both parts of the commissure of the cut valve flaps) and the seam allowance; and a portion for drawing a line including a closing portion forming a portion extending all the way to the portion forming the base of the cusps. Such a pattern is used to draw lines on the membrane to cut the membrane along the specified lines. Thus, materials for cutting and fabricating heart valve flaps can be provided.

List of bibliographic references

Patent document

[0003]

Patent Document: 1

Published Patent Document No. 5106019

Summary of the invention

Technical problem

[0004]

The template described in the above patent document 1 provides the manufacture of valve flaps from a material having a size including both the size of the flaps and the size of the allowance for the seam. It is desirable to evenly distribute the stresses acting on the valve flaps, and thus create more durable valve flaps. For this reason, there is a need to create a template for the manufacture of such wings.

Solution

[0005]

The present invention relates to a template for cutting sashes. The specified template for cutting the wings is a template according to which subsequently the parts forming the valve flaps are cut out in order to create the parts forming the wings for drawing the wings. In order to cut the material of the valves from the membrane, the lines (or points) are drawn on the membrane, drawn with the help of the part forming the wings of the valves, which is a reference point, thereby ensuring the cutting of the valve flaps from the material. In addition, when performing, for example, an operation using the aortic valvuloplasty technique, the shape of the cusps drawn with the part forming the cusps is suitable in the manufacture of such cusps.

[0006]

The present invention relates to a template for cutting sashes. Such a template for cutting the valves is used, for example, for operations on aortic valvuloplasty and (or) reconstruction of the aortic valve. In addition, such a template includes a part 11 forming the base of the flaps having a shape corresponding to the base of the flaps. The specified template for cutting the wings additionally includes parts 15 forming the wings, which are the corresponding parts of the wings provided outside of the part 11 forming the base of the wings.

[0007]

An example of a part forming the wings of a wing can be one or more holes provided on a part or on parts corresponding to the wing shape. Moreover, another example of the part forming the wings of the sash can be a guide part provided on the part corresponding to the shape of the wing. Preferably, each wing-forming part is provided, for example, on a part making up from more than 40% to less than 80% of the side surface of the part 11 forming the base of the flaps from the upper end of the side surface of the part 11 forming the base of the flaps.

[0008]

Preferably, the scale marking the stitched areas during the operation was provided on the respective parts 11, forming the base of the wings. Such a scale may be located equidistantly or may correspond to parts sewn in practice.

The beneficial effect of the invention

[0009]

When laying any sash material on the base of the template of the present invention, wing parts are formed on the side surfaces of the parts forming the sash. For example, such parts of the wings are folded back and stitched together with the artery, due to which a uniform distribution of the voltage acting on the sewn parts is ensured in such a way as to ensure the strength of the valve flaps.

Brief Description of the Drawings

[0010]

FIG. 1 is a schematic diagram illustrating an example of a template for sash cutting.

FIG. 2 is a perspective view of the template of FIG. one.

FIG. 3 is a schematic diagram illustrating corresponding examples of parts forming the base of the wings and parts forming the wings.

FIG. 4 is a perspective view of a template having parts forming the base of the wings and parts forming the wings illustrated in FIG. 3D

FIG. 5 is a schematic diagram illustrating an example of a casement material from which casements are patterned.

FIG. 6 is a conceptual diagram illustrating a state in which leaflet material is sutured to a blood vessel.

FIG. 7 is a snapshot, replacing the drawing, which shows the artery in which new valves are made during the reconstruction of the aortic valve using the template of the present invention.

Description of an embodiment of the present invention

[0011]

Preferred illustrative embodiments for implementing the present invention are described below with reference to the accompanying drawings. It should be noted that the present invention is not limited to the illustrative embodiments described below, but may also include an illustrative example or illustrative examples in which those skilled in the art may make modifications or changes depending on circumstances based on the following illustrative embodiments in limits not requiring clarification of the volume.

[0012]

The present invention relates to a template for cutting out valves of a heart valve. In FIG. 1 is a schematic diagram illustrating an example of a template for cutting sashes. In FIG. 2 is a schematic perspective view of the template of FIG. 1. Each template for cutting the valves is a template used, for example, when performing an operation using the technique of aortic valvuloplasty. In addition, as illustrated in FIG. 1, said pattern 13 includes parts 11 forming the base of the cusps, each part having a shape corresponding to the cusp base. In addition, the said pattern for cutting the wings includes parts 15 forming wings, which are corresponding parts of the wings provided outside the parts forming the base of the wings 11. The positions in FIG. 1 are numbers denoting corresponding sizers.

[0013]

In FIG. 3 is a schematic view illustrating examples of the parts forming the base of the wings and the wings forming the wings of the parts. In FIG. 3A, an example is illustrated in which the lateral upper end portion of each base-forming casement portion 11 is in a position corresponding to a commissure portion. As shown in the figure, the area surrounded by the edge of the sash-forming portion 11 and the dashed lines is the seam allowance. The indicated dashed lines indicate the shape of the wings. In this case, such an allowance for the seam 19 is provided within the area including the lower end part of the base portion of the wing 11. Several holes are made on both side surfaces of the base of the wing portion 11, with each hole serving as the wing portion of the wing portion 15.

[0014]

The upper part of the base portion of the sash portion 11 may have a rectangular shape similar to that described in the aforementioned Japanese Patent Publication No. 5106019, or may have the shape of a reverse trapezoid. Moreover, the inclined oblique sides can also be located in the direction of the upper center in addition to the rectangular shape or to the shape of the inverse trapezoid. Said upper portions are parts forming a closing zone, to which reference is made in the previously mentioned Japanese Patent Publication No. 5106019.

[0015] As forming the base of the sash portion 11 can be used forming the base of the sash portion, having a shape similar to that referred to in the publication of the previously mentioned Japanese patent No. 5106019. In FIG. 3B shows an example of a template having a size equal to the sum of the size of the seam allowance and the size of the flaps. In this case, the base of the flaps formed by the portion 11 forming the base of the flaps may be shaped taking into account the seam allowance in addition to the size of the actual flaps.

[0016]

Each of the wing-forming parts of the wings 15 may include a single hole, as illustrated in FIG. 3C. Due to the presence of such a hole, the membrane is cut out with such a hole, which is a mark, thereby ensuring the formation of a wing having a size suitable for the operation.

[0017]

Each of the wing forming parts of the wings 15 may be in the form of a slot, as illustrated in FIG. 3D A drawing tool moving along such slots draws lines that serve as a guide on the membrane when cutting such a membrane along parts of the wings. In FIG. 4 is a schematic perspective view of a template having parts forming the base of the flaps and parts forming the wings of the flaps, which are illustrated in FIG. 3D

[0018]

In FIG. 5 is a schematic view illustrating an example of a leaf material that is cut using a template. As illustrated in FIG. 5, said leaf material includes a leaf base 21 and wing portions 25. In addition, a scale 27 is drawn on the base of the 21 flaps, and a mark 28 is drawn on the lower end of the base of the 21 flaps.

[0019]

The wing-forming part 25 is a part attached to an artery, etc. in the folded state during the operation and overlaps with the base of 21 wings. It is contemplated that with this arrangement, the wing forming portion serves as a portion providing the seam allowance. The wing-forming portion is a backward curved portion. For this reason, it is preferable that the wing forming part of the wings does not extend along the entire perimeter, except for the upper surface forming the base of the wings of part 11, as in the case of the seam allowance described in Japanese Patent Publication No. 5106019, but may be performed, for example, on the part comprising from more than 40% to less than 80% (or from more than 50% to less than 70%) of the upper end of the side surface forming the base of the wings of part 11. The specified range is the range within which the vertical line runs in the direction enii downward from the midpoint of the line connecting the upper ends of the side surfaces of the two flaps forming the base portions 11, and it is assumed that the distance in the direction of the lower end flaps forming the base portion 11 is 100%.

[0020]

An example of the part forming the wings of the wings can be a single hole or several holes made in the area (or all) of the part corresponding to the part of the shape of the wing. Moreover, another example of the part forming the wings of the sash is the guide part provided on the part corresponding to the shape of the wing. The guide part is a slot for drawing, for example, lines corresponding to the wings. Such a slot can be used to provide tracing of points or lines that serve as a guideline for tracing the part forming the wing.

[0021]

It is preferable that a scale 27 be provided, indicating the stapled areas during the valve creation operation, such as aortic valvuloplasty or reconstruction of the aortic valve along the edge sections of the base portion of the sash 11. This scale can be performed equidistantly, or can be performed in accordance with the actual stitched sections. Such a scale can be performed, for example, on the edge sections of the base portion of the leaflet 11. The reconstruction of the aortic valve serves to completely replace the three folds of the valve with new leaflets, and aortic valvuloplasty allows you to leave at least one of the original folds of the valve when replacing the remaining one or several folds on a new sash or sash.

[0022]

The following is a description of an example of reconstruction of the aortic valve to create the aortic valve using materials for the valves, formed by the patient’s own pericardium. In this case, after opening the sternum, a median sternotomy is performed. Next, the pericardium is cut. Extracorporeal circulation based on cardiopulmonary bypass is carried out in a state in which, with an open heart, cardiac arrest is performed in order to expose the aortic valve or valve. On the other hand, previously obtained pericardiums are stretched with a thread to immerse them in a tissue fixation solution (for example, a solution containing glutaraldehyde) in which it is fixed.

[0023]

Then remove any of the three cusps of the aortic valve. Next, they provide a consistent contact of the sizer of the leaves with the part or parts that were cut to determine the size or dimensions (based on the distances between the parts of the commissure) of the cut leaves. The pericardium or pericardium is removed from the tissue fixative solution. Then, on the pericardium or pericardium, lines are drawn along the part 11 of the template forming the base of the leaflets, which corresponds to the leaflet sizer (a sizer having a size corresponding to the size of a part of the commissure of a cut leaf or leaflets). In particular, in view of the fact that the forming part of the sash base 11 is hollow, the drawing tool extends along the edge of the forming part of the sash part 11, thereby providing lines for the base of the sashes on the pericardium or pericardium. Since the lines for the base of the cusps drawn on the pericardium or pericardium serve as a guide during the operation, continuous lines can be used or lines or strokes can be used to indicate the main external shape of the fold of the valve. Next, each wing forming part 15 is used to draw corresponding marks on the wing forming part of the wings. The shape of the mark corresponding to the wing forming part of the wings of the wings may be different depending on the type of template. An example of a label corresponding to the wing-forming wings, can be lines or strokes in one or more areas, as described above. When using a template equipped with a scale on the part 11 forming the base of the sash, the marks indicating the areas sewn to the pericardium during the operation can be drawn depending on the circumstances, while the corresponding scale serves as a guide.

[0024]

Next, each pericardium is incised according to the marks corresponding to forming the wings of the valves of the part, which is a guide for obtaining the material of the valves. Such leaf material can be immersed, for example, in saline.

[0025]

In FIG. 6 is a conceptual diagram showing a state in which sash material is sutured to a blood vessel such as an aorta. As illustrated in FIG. 6A, the wing-forming portions of the leaf material portion 25 are bent so that the wing-forming portions 25 are located on the inside (i.e., they are bent in the form of a protrusion). The main work for the implementation of a more practical method of conducting the operation is similar to the work described in the publication of Japanese patent No. 5106019. More specifically, the mark 28, made in the position corresponding to the center point of the sash, is the top for passing the thread in the position indicated by the mark 28, for sewing the center point of the base 25 of the sash. Sewing is carried out in the direction of part of the commissure, while the center point is the starting point. Preferably, the distance between the needles is reduced within the area of the lower end of the base 25 of the cusps. In particular, it is preferable that the needle pitch is 1/3 (one third) compared with the portion of the lateral surface of the leaf base 25 within the portion of the lower end of the leaf base 25.

[0026]

When cross-linking is achieved in the area of the commissure part, the upper part scale allows the needle to project outward from the blood vessel. Then, when the stitching of the adjacent bases of the valves is completed, the upper part scale is left to project the needle outward from the blood vessel. A thread different from the thread used at the end, to which the needles are attached at both ends, extends outside the blood vessel into the blood vessel through the scale of the uppermost part on the wing-forming part of one leaf material. For an explanation from a more practical point of view, the thread is pulled from point A to point B. Next, the thread from point B is pulled through point D, and then pulled in the direction of the front side. On the other hand, the needle in the region of point A also passes through point C, and then exits in the direction of the front side. Thus, a situation arises when four needles are directed outside the blood vessel (Fig. 6A). Four indicated needles pass through one face (Fig. 6B). These four needles include: a needle used for suturing from the lower end of a certain material of the leaflets; a needle used for suturing from the lower end of the leaf material adjacent to a particular leaf material; and two needles provided on both sides of the thread extending along the upper part. Next, the thread is connected after passing through the front side (Fig. 6C). Thus, the fixation of the material of the valves to the blood vessel is ensured. The above example is intended as an example in which a medical thread is used to fix the leaf material to a blood vessel. However, the leaf material can be attached to the blood vessel by means other than a thread, for example, using a surgical stapler.

[0027]

In FIG. 7 is a snapshot, replacing the figure, which shows the artery in which the new valves are made during the reconstruction of the aortic valve using the template of the present invention.

Industrial applicability

[0028]

The present invention is intended for use in the field of medical equipment.

List of Reference Items

[0029]

11 - forming the base of the sash part,

13 is a template

15 is a part forming the wings,

17 - scale.

Claims (20)

1. A template (13) for cutting the valves of the heart valve, including a part (11) forming the base of the valves, having a shape corresponding to the base of the valves, so as to mark a line along the part (11) forming the base of the valves, further including: the part (15) forming the wings of the wings, which corresponds to the part of the wings provided outside the part (11) forming the base of the wings, so as to mark part of the wing. 2. The template according to claim 1, in which the part forming the wings of the wings includes one or more holes made in part or in parts corresponding to the shape of the wing or wings. 3. The template according to claim 1, in which the part forming the wings of the wings includes a guide part provided on the part corresponding to the shape of the wing. 4. The template according to claim 1, in which the part forming the wings of the wings is provided on the part comprising from more than 40% to less than 80% of the side surface of the part (11) forming the base of the wings from the end of the side surface of the part (11) forming the base of the wings. 5. The template according to claim 1, in which the part (11) forming the base of the wings is equipped with a scale (17), indicating the sewn part during the operation. 6. The template according to claim 1, in which the part (11) forming the base of the valves is equipped with an equidistant scale (17). 7. The template according to claim 1, in which the part (11) forming the base of the wings is a hole made in the template (13). 8. The template according to claim 1, in which part of the wing is bent back and sewn with the vessel participating in the operation. 9. The template according to claim 1, in which part of the wing is a part providing an allowance for the seam. 10. The template according to claim 1, in which part of the wing is part attached to the artery in the folded state during the operation, and overlaps with the base of the cusps. 11. A method of manufacturing the material of the valves used during aortic valvuloplasty or reconstruction of the aortic valve, including: marking the base of the cusps on the membrane by marking the line along the part (11) forming the base of the cusps in the template (13), while the part (11) forming the cusp base has a shape corresponding to the cusp base; marking one or more marks corresponding to the wing part on the membrane using the part (15) forming the wings of the wings in the template (13), while the wing part is provided with the possibility of its execution outside the part (11) forming the base of the wings; and membrane cutting taking into account the position of one or more tags.

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